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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06030414




Registration number
NCT06030414
Ethics application status
Date submitted
10/08/2023
Date registered
11/09/2023

Titles & IDs
Public title
A Study to Determine the Tolerability of Intranasal LMN-301
Scientific title
A Phase 1, Single-site, Open-label Study to Determine the Safety and Tolerability of Single and Multiple Doses of Intranasally Administered LMN-301 in Healthy Volunteers
Secondary ID [1] 0 0
COV01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - LMN-301

Experimental: Sentinel Cohort -

Experimental: Main Cohort Group 1 -

Experimental: Main Cohort Group 2 -

Experimental: Main Cohort Group 3 -


Treatment: Other: LMN-301
Intranasally administered powder.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Occurrence of adverse events as assessed by CTCAE v5.0 for 28 days after the first dose of LMN-301
Timepoint [1] 0 0
Daily for 28 days
Primary outcome [2] 0 0
Number of participants discontinuing from the study
Timepoint [2] 0 0
For 28 days after the first dose of LMN-301
Primary outcome [3] 0 0
Changes from baseline vital sign measures (systolic and diastolic blood pressure, pulse rate, oral temperature, and respiratory rate)
Timepoint [3] 0 0
In part A vital signs are measured on Days 1 (5 timepoints), 2, 8 and 14. In part B vital signs are measured on Days 1 (5 timepoints), 3 or 4, 7, 10 or 11, 14 and 28.
Primary outcome [4] 0 0
Changes from baseline safety laboratory measures (hematology, clinical chemistry and coagulation)
Timepoint [4] 0 0
For Part A on Days 1, 2, 8 and 14 and For Part B on Days 1, 3 or 4, 7, 14 and 28
Primary outcome [5] 0 0
Changes from baseline ECG parameters (PR interval, QRS duration, QTcB, QTcF and ventricular heart rate)
Timepoint [5] 0 0
Screening and Day 14
Primary outcome [6] 0 0
Changes from baseline nasal symptoms using the Sino-Nasal Outcome Test (total score)
Timepoint [6] 0 0
For Part A Days 1 and 8. For Part B Days 1, 7, 14 and 28

Eligibility
Key inclusion criteria
Individuals must meet all the following criteria to be eligible to participate in this study:

1. Adult (between 18 and 65 years of age) at screening
2. BMI = 18.0 and = 30.0 kg/m2, with a maximum body weight of 120 kg at screening.
3. General good health, without significant medical illness or abnormal physical examination findings per investigator discretion.
4. No clinically significant laboratory values at screening for haematology, serum chemistry, coagulation, and urinalysis in the opinion of the Investigator. A repeat test is allowed at the investigator's discretion.
5. Normal electrocardiogram (ECG) with no QTcF prolongation.
6. Must have provided written informed consent to participate in the clinical trial before any study-related activities are carried out and, in the Investigator's opinion, must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
7. In the investigator's opinion, participant is willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.

Female volunteers:

1. Must be of non-child-bearing potential, i.e., surgically sterilized (hysterectomy, bilateral salpingectomy, bilateral oophorectomy at least 6 weeks before the screening visit or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause (confirmed with FSH testing), or
2. If of child-bearing potential, must have a negative serum pregnancy test at screening and negative urine pregnancy test before the first study drug administration. They must agree not to attempt to become pregnant, must not donate ova, and must agree to use a highly effective method of contraception from signing consent, throughout the study and for at least 30 days after the last dose of study drug. For contraception guidelines see Appendix 4.

9. Male volunteers must agree not to donate sperm and if engaging in sexual intercourse with a female partner who could become pregnant, must agree to use a condom in addition to having the female partner use a highly effective contraceptive method (Appendix 4) from signing consent, during the study, and at least 90 days after the last dose of study drug.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion Criteria

Individuals will be excluded from this study if they meet any of the following criteria:
1. History or presence of clinically significant disease, including (but not limited to) clinically significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological or psychiatric disease, including any acute illness or surgery within the past 3 months prior to screening determined by the PI to be clinically relevant.
2. Known allergy or previous anaphylaxis to any components of the investigational product
3. Allergies, history of allergic disease or chronic respiratory diseases including mild asthma. History of childhood asthma or childhood allergies are not exclusionary.
4. History of nasal or upper respiratory pathology or abnormalities
5. Ongoing, defined as within 30 days of dosing through end of follow-up, usage of nasal spray or nasal drops
6. Treatment with an experimental device or compound within 30 days of the first dose of study drug.
7. Treatment within 30 days of the first dose of the study medication or planned use within the study period with immunomodulator or immunosuppressant agent or medicines (over the counter [OTC], herbal, prescription, or supplement) with significant activity in the respiratory tract.
8. Pregnancy, anticipated pregnancy, or breastfeeding/lactating
9. Alcohol or drug abuse/dependency (defined as more than 10 standard drinks per week or more than 4 standard drinks on any one day, where 1 standard drink is 10 g of pure alcohol) within 3 months prior to screening.
10. Positive urine toxicology screen for drugs of abuse. Repeat testing is allowed at investigator discretion. Tobacco or nicotine consumption is not permitted from screening and until the end of follow-up.
11. Positive alcohol breath test. Repeat test is allowed at investigator discretion.
12. Individuals unable or unwilling to provide adequate informed consent
13. COVID-19 positive
14. Positive test results for active human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies at screening.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/10/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/04/2024
Sample size
Target
Accrual to date
Final
35
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
CMAX Clinical Research - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Lumen Bioscience, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06030414